The content of the invention
In view of the problem that conventional membrane puncture needle has, present invention aim at provide it is a kind of have good compliance andThe membrane-repturing device that blood vessel passes through property, is suitable for various demands and is capable of the rupture of membranes of safety and precise.
To achieve these goals, the invention provides a kind of membrane-repturing device, it is characterised in that including：Membrane puncture needle；Double-deck sheathPipe, including the interior sheath outside the membrane puncture needle and the outer sheath being nested in outside interior sheath are nested in, and the interior sheath,Outer sheath can be relatively moved vertically each other with membrane puncture needle；And locating support, the locating support is by least one braidingSilk braiding is formed, and the distal end of the locating support is connected with interior sheath, and the near-end of locating support is connected with outer sheath, by controlRelative movement between interior sheath and outer sheath is controlling the expansion and contraction of locating support.
In a preferred embodiment, locating support has developing mark.For example, developing mark include it is following at leastIt is a kind of：The development silk that is included at least one braided wires, the developing ring being arranged on the locating support and it is coated inDevelopment point in braided wires.
In a preferred embodiment, the distal end of locating support is mutually fixed by hot melt adhesion with the interior sheath, describedLocating support is mutually fixed proximally by hot melt adhesion with the outer sheath.
In a preferred embodiment, at least one braided wires are made into the locating support by difference superimposing braid, adjacentBraided wires enclose and be set as network unit.Preferably, the scope at the obtuse angle of the network unit be 91-179 degree or100-160 degree or 110-150 degree or 115-140 degree or 120-135 degree.The shape of cross section of the braided wires is circular, ellipseCircular, trapezoidal, rhombus or rectangle.The braided wires are made up of any one in materials described below：Nitinol, 304 stainless steels,316L stainless steels, L605 cochromes and MP35N alloys.At least one string diameter of braided wires is 0.005 inch of -0.02 EnglishIt is very little.The lay of braiding of locating support is 0.6mm-1.5mm.Maximum outside diameter when locating support is in swelling state is 5 millimeter -40Millimeter.Locating support can be spherical, fusiformis, cylinder or conical support.Alternatively, at least one braided wires are by justRotation and derotation turn to the locating support.
In a preferred embodiment, film breaking needle set has the cutting tip for puncturing barrier film, and the cutting tip has developmentMark.Also, the other end relative with cutting tip of membrane puncture needle has scale mark.Preferably, membrane-repturing device also has and rupture of membranesThe stopping means that the other end of pin is engaged, for limiting the membrane puncture needle movement.Preferably, membrane puncture needle is hollow needle,Its hollow cavity is used to pass through for seal wire.The external diameter of membrane puncture needle is 0.3mm-1.5mm.Alternatively, membrane puncture needle is flexible optical fibre.
In a preferred embodiment, membrane-repturing device also includes locking device, the near-end phase of the locking device and interior sheathConnection, the distance between the distal end for locking interior sheath and outer sheath.
The present invention has following Advantageous Effects relative to prior art：
In the present invention, locating support is formed using at least one braided wires braiding so that locating support has goodIt is tensile strength, not easy to break, with good radial positioning power and compliance, can be good at adapting to blood vessel.
The locating support of braiding has engraved structure (adjacent braided wires are enclosed and are set as network unit), in rupture of membranesWhen do not influence normal blood flow, also, the spiral that carries of braided support, network can form good grappling effect, preventLocating support displacement during rupture of membranes.
In use, locating support progressively discharges, and can also reduce the injury to blood vessel.
Meanwhile, developing mark (silk that for example develops, developing ring, development point etc.) is added on locating support can make positioning branchFrame has preferable developability in vivo.
Additionally, locating support can be connected by hot melt adhesion technology with double-deck sheath, i.e., internal outer sheath carries out heat in itselfIt is fusible, be bonded compared to general glue etc., not only bonding strength is high, tensile strength is good, good by property, and is not inIntroduce the potential danger of other compositions.
Developing mark is set by the distal end of membrane puncture needle (cutting tip) so that the distal end of membrane puncture needle has preferably developmentProperty, it is possible to achieve accurate rupture of membranes.Scale mark is set by near-end (other end relative with cutting tip) in membrane puncture needle, can be withDetermine the entrance depth of membrane puncture needle, while setting stopping means, the entrance depth of membrane puncture needle can be controlled, prevent from entering because of membrane puncture needleEnter long and damage, realize the rupture of membranes of safety and precise.Further, by the hollow design of membrane puncture needle, its inner chamber can lead toSeal wire is crossed, seal wire can smoothly follow up so after rupture of membranes, be further to operate provides convenient.
Membrane-repturing device of the invention is performed the operation for Endovascular, for example, can be used for diaphragm type Bu-plus Cotard and overlay film branchSupport body open interior, with good compliance and blood vessel by property, is suitable for various demands, in combination with the aobvious of locating supportShadow, the distal end development of membrane puncture needle, the locator of near-end and scale positioning are capable of the rupture of membranes of safety and precise.
Specific embodiment
It is described in detail to various aspects of the present invention below in conjunction with the drawings and specific embodiments.Wherein, in accompanying drawingPart be not necessarily drawn to scale, it focuses on being illustrated principle of the invention.
In various embodiments of the present invention, it is thus well known that structure or material are not shown or do not elaborate.AndAnd, described feature, structure or characteristic can by any way be combined in one or more implementation methods.Additionally, this areaIt will be appreciated by the skilled person that following various implementation methods are served only for for example, not for limitation protection model of the inventionEnclose.Can also be readily appreciated that, the part in each implementation method described herein and shown in the drawings can by various different configurations orRatio is arranged and designs.
【First embodiment】
Fig. 1 is the schematic diagram of the membrane-repturing device according to one embodiment of the present invention；Fig. 2 a and Fig. 2 b are the membrane-repturing devices in Fig. 1Schematic diagram during use；Fig. 3 is enlarged diagram when membrane-repturing device in Fig. 1 punctures film.
As shown in figure 1, membrane-repturing device of the invention includes：Membrane puncture needle 1, double-deck sheath 2 and locating support 3, wherein, double-deck sheathPipe includes the outer sheath 22 for being nested in interior sheath 21 outside membrane puncture needle and being nested in outside interior sheath, and interior sheath 21, outerSheath 22 and membrane puncture needle 1 can be relatively moved vertically each other, and specifically, interior sheath 21 axially opposed can be moved with outer sheath 22Dynamic, membrane puncture needle 1 can be moved axially relatively with interior sheath 21；Locating support 3 is formed by least one braided wires braiding, positioning branchThe distal end of frame 3 is connected with interior sheath 21, and the near-end of locating support 3 is connected with outer sheath 22, by sheath and outer sheath in controlBetween relative movement controlling the expansion and contraction of locating support.For example, the length for being shorter in length than interior sheath 21 of outer sheath 22Degree, the distal end of locating support 3 is connected with the distal portions of interior sheath 21, and the near-end of locating support 3 connects with the distal end of outer sheath 22Connect, when certain distance is pulled open in the distal end of double-deck sheath, locating support is in contraction state, when the distal end of double-deck sheath is in external forceLocating support is in expansion softened state when being drawn close under promotion.The length of membrane puncture needle 1 is longer than double-deck sheath, also, in positioning branchFrame is in mobile membrane puncture needle 1 under expansion softened state, its cutting tip is stretched out from the distal end of interior sheath 21 and punctures corresponding film.
Preferably, locating support 3 have developing mark, for example, can include it is following at least one：It is included at leastDevelopment silk in a piece braided wires, the developing ring being arranged on locating support are (for example, developing ring can be arranged on the distal end of supportAnd near-end, C-shaped or circular ring-type) and the development point that is coated in braided wires etc., or other enable locating support 3Other marks of enough developments.Developed by making locating support, can be in order to determine locating support position in vivo, to ensure brokenlyThe accuracy of film needle-penetration film.
In the present embodiment, locating support 3 is made into by least one braided wires by difference superimposing braid, adjacent braided wiresEnclose and be set as network unit, specifically, difference is folded when referring to once to contact braided wires a is above braided wires b, contact next timeWhen braided wires a be wound through the cross-over principle below braided wires b.Wherein, the scope at the obtuse angle of network unit can be withIt is 91-179 degree or 100-160 degree or 110-150 degree or 115-140 degree or 120-135 degree, preferably 120-135 degree.It is fixedThe lay of braiding (that is, two air line distance in crosspoint vertically) of position support is 0.6mm-1.5mm, and preferably 1.0mm is (in figureUnder contraction state shown in 1).The string diameter of braided wires can be 0.005 inch -0.02 inch.The shape of cross section of braided wires canThink circular, oval, trapezoidal, rhombus or rectangle etc..Braided wires can be made up of any one in materials described below：NiTi is closedGold, 304 stainless steels, 316L stainless steels, L605 cochromes and MP35N alloys etc., preferably nitinol alloy wire so that braiding andInto locating support there is more preferable radial positioning power and compliance.Locating support can be spherical, fusiformis, cylinder or taperSupport.The maximum outside diameter of (that is, the swelling state of the locating support 3 shown in Fig. 2 b and Fig. 3) when locating support is in swelling stateIt is 5 millimeters -40 millimeters.
In the present embodiment, braided wires without dextrorotation derotation coiling (that is, braided wires first dextrorotation coiling from front to back, thenDerotation coiling from back to front) locating support is formed, the two ends (free end) of braided wires are located at the two ends of locating support, Ke YizhiConnect and mutually fixed with interior sheath 21 and outer sheath 22.In other embodiments, the locating support 3 can also be by least one volumeSilk is knitted to be turned to by dextrorotation and derotation, now, two ends (that is, longitudinal end) imperforation of locating support, respectively with interior sheath 21Mutually fixed with outer sheath 22.
In the present embodiment, the distal end of locating support 3 is mutually fixed by hot melt adhesion with interior sheath 21, locating support 3Mutually fixed with outer sheath 22 proximally by hot melt adhesion.In the present invention, hot melt adhesion refers to, for example, the interior sheath of heating is remoteEnd part, melts its part, and the distal end of locating support is put in the part of interior sheath distal end fusing, is cooled down after compression, you canThe distal end and the distal end of interior sheath 21 for making locating support are mutually fixed.Compared to common gluing connection, hot melt adhesion will not be introducedNew binder material, but be directly bonded using sheath itself, such bonding connection intensity is high and for medical treatmentFor required environment, the potential danger for introducing other compositions is not had.It is however also possible to will be positioned using other modes such as gluingSupport is mutually fixed with interior sheath 21 and outer sheath 22 respectively, for example, divided locating support using medically acceptable adhesive etc.Do not fixed mutually with interior sheath 21 and outer sheath 22.
As shown in figure 1, membrane puncture needle 1 can have the cutting tip 11 (distal end) for puncturing barrier film, the cutting tip 11 can haveDeveloping mark, for example, can be that developing material is coated in point or ring of formation etc. on cutting tip, or other can cause cutting tipThe mark of distal end development.The other end (near-end) relative with cutting tip 11 of membrane puncture needle 1 has scale mark 12.And membrane-repturing deviceAlso there is the stopping means 13 for limiting membrane puncture needle movement engaged with the other end (near-end) of membrane puncture needle.Stopping means 13Nut groove and fixing nut can be included, by tightening fixing nut in nut groove, fixing nut can be made tight with membrane puncture needleContiguity is touched to increase the two frictional force so that the two is fastened to each other.The length that membrane puncture needle rupture of membranes enters can be by the quarter of near-endFind out in scale designation (length mark).After length is limited, fixing nut is tightened to limit membrane puncture needle movement, it is so, longDegree can be just fixed without changing.
The external diameter of membrane puncture needle is 0.3mm-1.5mm.In a preferred embodiment, membrane puncture needle is hollow needle, and its is hollowInner chamber is used to pass through for seal wire 6.In another preferred embodiment, membrane puncture needle is flexible optical fibre, and film is punctured by laser.
Membrane-repturing device also includes locking device 4, and locking device 4 is connected with the near-end of interior sheath 21, for locking interior sheath21 the distance between with the distal end of outer sheath 22.Locking device 4 is fastening screw, by tightening the fastening screw, can be lockedInterior sheath is no longer moved, so as to lock the distance between distal end of interior sheath 21 and outer sheath 22.
Membrane-repturing device also includes interior sheath pipe joint 51, epitheca pipe joint 52 and rupture of membranes adapter 53, interior sheath pipe joint and interior sheathThe proximal end of pipe is connected, and epitheca pipe joint is connected with the proximal end of outer sheath, and rupture of membranes adapter is near with membrane puncture needleEnd end is connected, and these joints are easy to doctor's movement interior sheath, outer sheath and membrane puncture needle in operation.Alternatively, in epithecaAt pipe joint 52, flushing hole 54 is additionally provided with, the flushing being available in double-deck sheath and radiography.
Additionally, as shown in Figure 2 a and 2 b, when usually using the membrane-repturing device, can first introduce (that is, the blood of dilating catheter sheath 7Enlargement of pipe device), the interior outer sheath of membrane-repturing device is delivered to by relevant position by the catheter sheath 7.
Understood with reference to Fig. 3, in use, membrane-repturing device is delivered into the target location in blood vessel 8, operate the interior of membrane-repturing deviceOuter sheath 21,22 is so that the expansion fixation of locating support 3, it (can be that Bu-plus Cotard are made that operation membrane puncture needle 1 passes through target film 9Into blood vessel barrier film or narrow, or overlay film frame film), carry out rupture of membranes.
Membrane-repturing device of the invention can be disposable, it is also possible to be packaged in bag after using any suitable technology sterilizationIn son, box or other suitable containers.For example, the membrane-repturing device of single use can pack sale together with protection coil pipe,When membrane-repturing device is taken out, it is possible to use physiological saline rinses the membrane-repturing device.
【Second embodiment】
Embodiments of the present invention additionally provide a kind of operating method of above-mentioned membrane-repturing device, and methods described includes following stepSuddenly：
A. hollow lancet puncture is entered into human menstruation blood pipe to target location.In the step, in usual surgical procedure, needWill first after site of puncture carries out conventional transdermal sterilization, local anaesthesia afterwards, then cut point of puncture skin about 2 with scalpel point of a knifeThe otch of~3mm, is afterwards punctured puncture needle through skin incision, and in operation, left hand refers to pins target to userArterial proximal, needle angle diagonal inserting needle on request, seeing has pulsation blood flow to spray, and represents that syringe needle has been located in intra-arterial, soThe pin heart is extracted afterwards.
B. blood vessel is stretched into by seal wire is punctured by puncturing Aculeata, is slowly extracted during insertion punctures seal wire and puncturedPin.After puncture seal wire confirms to enter artery, extract puncture needle and simultaneously compel point of puncture with hand pressure, prevent bleeding.
C. dilating catheter sheath 7 (vessel dilator) is stretched into blood vessel to target location through puncturing seal wire guiding, is pulled out afterwardsGo out to puncture seal wire.In operation, it is necessary to note：Puncturing seal wire must expose the tail end of catheter sheath 7, in order to avoid puncture seal wire take offFall into vivo.After catheter sheath 7 is sent into intra-arterial, then seal wire extraction will be punctured.
D. seal wire 6 is fed through target location by stretched catheter sheath 7；It is motionless that the seal wire 6 is fixed afterwards.
E. the interior outer sheath of membrane-repturing device is fed through target location by stretched catheter sheath 7 along seal wire 6；The outer sheath in promotingDuring, operator needs discontinuity injecting heparin physiological saline.
F. at propulsion membrane-repturing device to rupture of membranes, discharge locating support 3 and lock the radical length of the support and the maximum of expansionExternal diameter.In operation, it is necessary to note：Locating support is needed it is determined that being expanded again behind position and being fixed.With reference to Fig. 2 aWith Fig. 2 b, it can be seen that locating support is released and expands fixation.
G. seal wire 6 is recalled into membrane puncture needle 1, it is slow to push membrane puncture needle to target location until rupture of membranes.The process needsWith reference to the scale mark 12 and stopping means 13 of membrane puncture needle near-end, to determine that membrane puncture needle enters to correct position and do not move；Such asFruit can not smoothly rupture of membranes, it is necessary to readjust the stopping means of near-end with rupture of membranes again.In this step, recalled by by seal wire 6To membrane puncture needle 1, can prevent from injuring seal wire or influence rupture of membranes effect during propulsion membrane puncture needle.The stopping means of the near-end of membrane puncture needleNeed to be adjusted to correct position and fixation, it is long to prevent membrane puncture needle from entering, injure to vascellum laterale and surrounding tissue.
H. follow up seal wire 6 (will seal wire 6 stretched into inside from the cut of film) after the completion of rupture of membranes, after seal wire by after holesRecall membrane puncture needle.
I. locating support is shunk by the distance between outer sheath head end in regulation, slowly withdraws to pack up along interior outer sheath and determinePosition support simultaneously withdraws from membrane-repturing device along dilating catheter sheath 7.
J. suitable sacculus may be selected after rupture of membranes to arrive at broken hole position along seal wire and expanded.Then carrying out follow-up workMake.
In surgical procedure, using before rupture of membranes apparatus, it is necessary to first be carried out disinfection to puncture needle, scalpel, catheter sheath etc.Prepare.Also, because seal wire typically packs sale together with seal wire protection coil pipe, application syringe is to coil pipe before taking out seal wireThe enough heparinized salines of middle injection, so as to aquation seal wire coating.
The term and wording used in description of the invention for example, being not intended to constitute just to limiting.AbilityField technique personnel should be appreciated that on the premise of the general principle of disclosed implementation method is not departed from, to above-mentioned implementation methodIn each details can carry out various change.Therefore, protection scope of the present invention only determined by claim, in the claims,Unless otherwise indicated, all of term should be understood by the broadest rational meaning.